ETHICON, INC.: Device Recall

Recall #Z-0487-2025 · 10/08/2024

Class II: Risk

Recall Details

Recall Number: Z-0487-2025
Classification: Class II
Product Type: Device
Recalling Firm: ETHICON, INC.
Status: Ongoing
Date Initiated: 10/08/2024
Location: Juarez, N/A, Mexico
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,524 devices

Reason for Recall

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

Product Description

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.

Distribution Pattern

U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.

Other Recalls by ETHICON, INC.

Class II: Risk 09/25/2024

Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

View all recalls by ETHICON, INC. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.